Comparison of the efficacy between Bofutsushosan and Daisaikoto in sleep apnea patients complicated with persistent obese and hypertension

Acronym

The efficacy of Japanese herbal medicines in sleep apnea patients complicated with persistent obese and hypertension

Scientific Title

Comparison of the efficacy between Bofutsushosan and Daisaikoto in sleep apnea patients complicated with persistent obese and hypertension

Scientific Title:Acronym

The efficacy of Japanese herbal medicines in sleep apnea patients complicated with persistent obese and hypertension

Region

Japan

Condition

Condition

Obstructive sleep apnea syndrome, Hypertension, Obesity

Classification by specialty

Medicine in general

Cardiology

Pneumology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

We will evaluate the efficacy of two Japanese herbal medicines, Bofutsushosan and Daisaikoto, in patients with sleep apnea syndrome. The subjects are obstructive sleep apnea patients complicated with persistent obesity and hypertension despite of treatment with continuous positive airway pressure (CPAP) or oral appliance.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

Change in body weight

Key secondary outcomes

Blood pressure,Visceral fat accumulation

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bofutsushosan 7.5g per day for 6months.

Interventions/Control_2

Daisaikoto 7.5g per day for 6months.

Interventions/Control_3

control(when the patients refused to take the medication)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Persistent obesity and hypertension despite of 6 months of continuous positive airway pressure(CPAP) treatment for obstructive sleep apnea(OSA).
2.Obesity is defined as body mass index(BMI)>= 25kg/m2.
3.Hypertension is defined as systolic blood pressure(BP)>=130mmHg or diastolic BP>=80mmHg in more than twice determination.
4.OSA is defined as 1)sleepiness, apnea hypopnea index (AHI)>=5 and more than half of apnea is obstructive 2)AHI>=15 with or without OSA related symptoms. AHI is determined with polysomnography.
5.Undergoing appropriate nutrition and exercise therapy.
6.Patients using oral appliance will not be randomized. They will be instructed to start Bofutsushosan only.